Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients

Chang Gung Medical Foundation

Status: Unknown

Conditions: Snoring; Apnea, Obstructive Sleep

Treatments: Device: acupuncture press needle

Study type: Interventional

Funder types: Other

Identifiers

NCT04143022

201801807A3

Details and patient eligibility

About

The aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients.

Full description

Obstructive sleep apnea(OSA) is characterized by multiple episodes of upper airway collapse during sleep and considered as a major health issue worldwide due to comorbidity with obesity, hypertension, diabetes and more advanced cardiovascular diseases. The noisy sounds of snoring caused by OSA bother bed partner sleepless and lead to long-term health problems. Most patients do not tolerate nasal continuous positive airway pressure device, which is the gold standard treatment of OSA. Press needle is one kind of acupuncture which possesses more safety and convenient, few complications and prolonged period of treatment time compared to conventional acupuncture. To date, there is no study to evaluate the effects of press needle in treating OSA. The investigators hypothesize that press needle is effective with high acceptability among OSA patients.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to sign inform consent with aged more than 20 years old
• Mild to moderate OSA, AHI < 30

Exclusion criteria

• Severe OSA, AHI > 30
• Significant lung disease
• Skeletal facial framework problems
• Central apnea
• Undergone oropharyngeal operations, continuous positive airway pressure or oral devices
• Taking hypnotic drugs
• Pregnancy or breast-feeding
• Receiving acupuncture in recent 2 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

group A (acupuncture press needle)

Active Comparator group

Description:

Group A subjects first receive acupuncture press needle treatment at acupoint of Jin's 3-tongue point and EX-HN25. Then, it takes 2-week washout period. After washout period, subjects receive another course of treatment at acupoint of EX-CA1, EX-CA5 and EX-CA6. Each subject receive 2 times a week of treatment for 4 weeks (8 times in total) in each course.

Treatment:

Device: acupuncture press needle

group B (acupuncture press needle)

Active Comparator group

Description:

Group B subjects first receive acupuncture press needle treatment at acupoint of EX-CA1, EX-CA5 and EX-CA6. Then, it takes 2-week washout period. After washout period, subjects receive another course of treatment at acupoint of Jin's 3-tongue point and EX-HN25. Each subject receive 2 times a week of treatment for 4 weeks (8 times in total) in each course.

Treatment:

Device: acupuncture press needle